Analysis of the Changing Economics of US Hospital Transcatheter Aortic Valve Replacement Programs

New technologies in medicine, even if they are promising medically, are often expensive and logistically difficult to implement at the hospital level. Transcatheter aortic valve replacement (TAVR) is a model technology that is revolutionary in treating aortic stenosis, but has been plagued with significant challenges with financial sustainability. In this article, a margin analysis at the hospital level was performed using literature data. A TAVR industry analysis was performed using Porter’s Five Forces framework. The data indicate that TAVR is more expensive than surgical aortic valve replacement, although the cost of TAVR is declining with the use of an optimized minimalist protocol. The overall industry is growing as its clinical indications expand, and it will likely undergo significant reduction of costs when new valves enter the US market. As such, TAVR is a growing industry, with financial sustainability currently dependent on operational efficiency. A concluding list of specific program interventions is provided to help TAVR programs improve operational efficiency and clinical outcomes, as well as help decide whether to create, expand, or redirect funding for TAVR programs. Importantly, the frameworks used to analyze this rapidly evolving technology can be applied to other new technologies to determine financial sustainability.     

Natural History of Mitral Annular Calcification and Calcific Mitral Valve Disease

Progression to severe MAC and CMVD according to MAC severity and sex.

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Prevalence and Natural History of Mitral Annulus Calcification and Related Valve Dysfunction

ObjectiveTo evaluate the prevalence and natural history of mitral annulus calcification (MAC) and associated mitral valve dysfunction (MVD) in patients undergoing clinically indicated echocardiography.MethodsA retrospective review was conducted of all adults who underwent echocardiography in 2015. Mitral valve dysfunction was defined as mitral regurgitation or mitral stenosis (MS) of moderate or greater severity. All-cause mortality during 3.0 (0.4 to 4.2) years of follow-up was compared between groups stratified according to the presence of MAC or MVD.ResultsOf 24,414 evaluated patients, 5502 (23%) had MAC. Patients with MAC were older (75±10 years vs 60±16 years; P<.001) and more frequently had MVD (MS: 6.6% vs 0.5% [P<.001]; mitral regurgitation without MS: 9.5% vs 6.1% [P<.001]). Associated with MS in patients with MAC were aortic valve dysfunction, female sex, chest irradiation, renal dysfunction, and coronary artery disease. Kaplan-Meier 1-year survival was 76% in MAC+/MVD+, 87% in MAC+/MVD?, 86% in MAC?/MVD+, and 92% in MAC?/MVD?. Adjusted for age, diabetes, renal dysfunction, cancer, chest irradiation, ejection fraction below 50%, aortic stenosis, tricuspid regurgitation, and pulmonary hypertension, MAC was associated with higher mortality during follow-up (adjusted hazard ratio, 1.40; 95% CI, 1.31 to 1.49; P<.001); MVD was associated with even higher mortality in patients with MAC (adjusted hazard ratio, 1.79; 95% CI, 1.58 to 2.01; P<.001). There was no significant interaction between MAC and MVD for mortality (P=.10).ConclusionIn a large cohort of adults undergoing echocardiography, the prevalence of MAC was 23%. Mitral valve dysfunction was more than twice as prevalent in patients with MAC. Adjusted mortality was increased in patients with MAC and worse with both MAC and MVD.     

Clinical Outcomes of Adults With Bicuspid Aortic Valve: A European Perspective

ObjectiveTo describe the clinical history of patients with a wide age range diagnosed with bicuspid aortic valve (BAV) and no surgical indication and to evaluate the long-term outcome of patients with BAV referred for elective surgery.Patients and MethodsBetween 2005 and 2017, 350 consecutive patients with no surgical indication (surveillance group, mean age 53±16, 71% men) and 191 with a surgical indication (surgical group, mean age 59±13, 71% men) were prospectively included. Median follow-up was 80 (32 to 115) months.ResultsIn the surveillance group, the 5-year and 10-year survival rates were 93±1% and 89±2%, respectively, with a relative survival of patients with BAV compared with an age- and sex-matched control population of 98.7%. During follow-up, the cumulative 10-year incidence of aortic valve and aorta surgery was high; of 35±4%, the incidence of native valve infective endocarditis (IE) of 0.2% per patient-year, and no cases of aortic dissection were observed. In the surgical group, the 5-year and 10-year survival rates were 97±1% and 89±3%, respectively, with a relative survival of 99.4% compared with the general population. The incidence of IE was 0.4% per patient-year, and no cases of aortic dissection were observed.ConclusionThis regional cohort shows that the 10-year survival rates of patients with BAV and a wide age range, but mostly middle-aged adults, were similar to those of the general population with a very low rate of complications. Adherence to prophylactic surgical indications and younger age might have contributed to this lack of difference.